Regulation (EC) No 1223/2009 requires a Product Information File (PIF) should ready for all Cosmetics intended for marketing within the EU.
CPSR stands for Cosmetic Product Safety Report. It is a document that summarizes the safety assessment of a cosmetic product and provides evidence to support its safety for human use. The CPSR is an important part of the regulatory process for cosmetic products, and it is typically required by the relevant governing body, such as the European Commission or the US Food and Drug Administration (FDA).
The CPSR typically includes information on the product's ingredients, manufacturing processes, and the results of any toxicity, dermatological, and clinical tests performed. It also includes a risk assessment that considers the potential exposure to the product and the potential for any adverse effects.
The CPSR is a key document for ensuring the safety of cosmetic products, and it is an important tool for regulators to assess the safety of cosmetic products before they are allowed to be sold to the public.
The CPSR is the main section of the Product Information File (PIF) a scientific investigation into the safety of a cosmetic product. The CPSR (Cosmetic Product Safety Report) has two parts:
Part A - Information on the safety of cosmetic product and Part B - Cosmetic products Safety Assessment The cosmetic safety Assessment of cosmetic safety should include the following information:
1. The quantitative and qualitative compositions of the cosmetic product;
2. The physical/chemical property and stability of the cosmetic product;
- The physical/chemical properties of the substances or mixtures;
- Physical/chemical properties of the Finished cosmetic product;
3. Microbiological quality (control of the effectiveness of preservatives in cosmetics and skin care products);
4. Impurities, packaging material information;
5. Description of use;
6. Effect of the cosmetic product;
7. Exposure to components/substances;
8. Toxicological profile of substances;
9. Undesirable effects and serious undesirable effects when using cosmetic products;
10. Information about the cosmetic product.
The following documents are typically required for a Cosmetic Product Safety Report (CPSR):
Ingredient list: A complete list of all ingredients in the cosmetic product, including their INCI (International Nomenclature of Cosmetic Ingredients) names and percentages of use.
Product formulation: Information on the product's formulation, including its pH, viscosity, and any preservatives or stabilizers used.
Safety data sheets (SDS) for each ingredient: An SDS is a document that provides information on the physical, environmental, and health hazards associated with an ingredient.
Toxicology data: Results from any toxicology testing performed on the product or its ingredients, including data on skin irritation, eye irritation, skin sensitization, and acute toxicity.
Clinical data: Results from any clinical testing performed on the product, including data on skin irritation, skin sensitization, and other relevant parameters.
Microbiology data: Results from any microbiological testing performed on the product, including data on preservative efficacy and the presence of any harmful microorganisms.
Product stability data: Results from any stability testing performed on the product, including data on changes in appearance, odor, pH, and consistency over time.
Risk assessment: A comprehensive risk assessment that considers the potential exposure to the product and the potential for any adverse effects.
Conclusion: A conclusion that summarizes the results of the safety assessment and provides evidence to support the product's safety for human use.
These documents should be organized in a clear and concise manner, using appropriate
The CPRS file is carried out by people specialised in cosmetic products. These people are : a natural person who carries out the cosmetic product Safety Assessment, and who is in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or similar discipline, or a course recognised as equivalent by a Member State. (Art 10.2).
If all your documents are complete, you can have a CPSR file at a very affordable price.
The CPSR (Cosmetic Product Safety Report) is typically reviewed by the relevant regulatory authority, such as the European Commission or the US Food and Drug Administration (FDA). The CPSR should be written in a clear and concise manner, using appropriate scientific language, and should be in the official language of the regulatory authority. In the European Union, this is typically in English, French, or German, while in the US, it is typically in English. It is important to ensure that the CPSR is written in a clear and understandable manner, and that it provides a complete and accurate assessment of the cosmetic product's safety. This can help to ensure that the regulatory authority is able to quickly and effectively assess the product's safety and approve it for sale to the public.
A PIF (Product Information File) is a document that provides information on a cosmetic product and its ingredients. The PIF is a key component of the regulatory process for cosmetic products, and it is typically required by the relevant governing body, such as the European Commission or the US Food and Drug Administration (FDA).
The PIF typically includes information on the product's ingredients, manufacturing processes, and any relevant safety data. It may also include information on the product's labeling, packaging, and advertising, as well as any relevant standards or regulations that apply to the product.
The PIF is an important tool for ensuring the safety and compliance of cosmetic products, and it is used by regulators to assess the product's safety before it is allowed to be sold to the public. It is also used by cosmetic companies to keep track of their products and to provide relevant information to customers, regulators, and other stakeholders.
It is important to keep the PIF up-to-date and accurate, and to regularly review and update it as necessary to ensure that it remains in compliance with relevant regulations and standards.
Yes we have; there is an online base system that step by step you can upload your files . We are still developing